Healthcare Industry News: Vidaza
News Release - May 16, 2006
Pharmion Announces Start of Phase 1 Trial Evaluating Satraplatin Plus Xeloda(R) in Patients With Advanced Solid TumorsFirst Study to Evaluate Satraplatin in Combination With Another Oral Chemotherapy
BOULDER, Colo., May 16 (HSMN NewsFeed) -- Pharmion Corporation (Nasdaq: PHRM ) today announced that a Phase 1 study evaluating satraplatin in combination with Xeloda® (capecitabine) in patients with advanced solid tumors has opened for accrual. Xeloda is an oral form of 5-FU, a marketed chemotherapy treatment that is used to treat various cancers, including metastatic breast and colorectal cancers.
The Phase 1 study is an open label study being conducted at Northwestern University Medical Center in Chicago under the direction of William Gradishar, M.D., Professor of Medicine, Director Breast Medical Oncology. The primary objective of this study is to determine the maximum tolerated dose for satraplatin in combination with Xeloda in patients with advanced solid tumors. The trial is expected to enroll up to 24 patients.
Dr. Gradishar commented: "Combinations of intravenous 5-FU and certain marketed platinum compounds have shown activity in a number of cancers. I am excited about the potential that the combination of satraplatin and Xeloda may hold. This oral-oral regimen, if effective, may offer doctors an important new, well tolerated and convenient treatment option for patients with a variety of cancers."
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home.
In December 2005, GPC Biotech completed accrual to the SPARC trial and initiated the rolling submission of a New Drug Application (NDA) for satraplatin with the U.S. Food and Drug Administration (FDA). Also in December 2005, GPC Biotech signed a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion was granted exclusive commercialization rights to satraplatin for Europe and certain other territories.
Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in HRPC, ovarian cancer and small cell lung cancer. Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned.
Pharmion is a biotechnology company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S., Europe and additional international markets. Pharmion has a number of products on the market including the world's first approved epigenetic cancer drug, Vidaza®, a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at www.pharmion.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Pharmion's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include the status and timing or regulatory approvals for Pharmion's product candidates; the impact of competition from other products under development by Pharmion's competitors; the regulatory environment and changes in the health policies and structure of various countries; acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of products newly launched, currently being sold or in development; Pharmion's ability to successfully acquire rights to, develop and commercialize additional pharmaceutical products; failure of third-party manufacturers to produce the product volumes required on a timely basis, fluctuations in currency exchange rates, and other factors that are discussed in Pharmion's filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and Pharmion undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
Xeloda® (capecitabine) is a registered trademark of Hoffmann-la Roche AG.
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